The Federal Drug Administration has approved a clinical trial to test the effectiveness of a new electronic grid that records brain activity during surgery. Developed by engineers at the University of California San Diego, the device has nanoscale sensors that record electrical signals directly from the surface of the human brain in record-breaking detail.

The grid’s breakthrough high resolution could provide better guidance for planning and performing surgeries to remove brain tumors and treat drug-resistant epilepsy and could improve neurosurgeons’ ability to minimize damage to healthy brain tissue, the researchers say. During epilepsy surgery, the novel grid could also improve the ability to precisely identify the regions of the brain where epileptic seizures originate, allowing for safe, effective treatment.

Ultra-thin brain sensor array

The new brain sensor array ( known as “platinum nanorod grid (PtNRGrid)” features a densely packed grid of a record-breaking 1,024 embedded electrocorticography (ECoG) sensors. The device rests on the surface of the brain and is approximately 6 microns thin and flexible. So it can both adhere and conform to the surface of the brain, bending as the brain moves while providing high-quality, high-resolution recordings of brain activity. 

In contrast, the ECoG grids most commonly used in surgeries today typically have between 16 and 64 sensors and are rigid, stiffer and more than 500 microns in thickness; and do not conform to the curved surface of the brain.

The PtNRGrid was invented by Shadi Dayeh, a Professor in the Department of Electrical and Computer Engineering at the University of California San Diego and members of his team. The team developed the PtNRGrid technology in collaboration with neurosurgeons and medical researchers from UC San Diego, Massachusetts General Hospital (MGH) and Oregon Health & Science University (OHSU).

Currently, Dayeh’s research group holds the world record for recording brain activity from a single cortical grid with 2,048 channels on the surface of the human brain, published in Science Translational Medicine in 2022.

The clinical trial is designed to demonstrate the effectiveness of the PtNRGrid device to map both normal and pathological brain activity. Surgeons will implant the PtNRGrid in 20 patients, then measure and compare the grid’s performance with the present state-of-the-art. The PtNRGrid will be deployed in surgeries to remove brain tumors and to remove tissue that causes epileptic seizures.

“Our goal is to provide a new atlas for understanding and treating neurological disorders, working with a network of highly experienced clinical collaborators at UC San Diego, MGH, and OHSU,” Dayeh said in a statement.

Record-breaking density

Pending the success of this staged trial, the team will transition to the next crucial step: making the PtNRGrid available for commercial use at scale. Demonstrating that ECoG grids with sensors in the thousands of channels record brain activity with high fidelity also opens new opportunities in neuroscience for uncovering a deeper understanding of how the human brain functions. Basic science advances, in turn, could lead to improved treatments grounded in an enhanced understanding of brain function.

Dayeh’s work toward the FDA approval is supported by an NIH BRAIN® Initiative award.

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